Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Safe Orthopaedics — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

72 daysmedian FDA review time
98 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201648Sterispine™ PSSafe Orthopaedics2020-07-30420
K170528Sterispine™ PSSafe Orthopaedics2017-03-09150
K162531STERISPINE CCSafe Orthopaedics2016-12-291110
K151921STERISPINE PSSafe Orthopaedics2015-10-08870
K151747STERISPINE PSSafe Orthopaedics2015-10-05980
K151756STERISPINE LC CAGESafe Orthopaedics2015-08-21530
K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics2015-02-10250
K140802STERISPINE PSSafe Orthopaedics2014-06-04650
K133893STERISPINE LC CAGESafe Orthopaedics2014-03-14840
K130632STERISPINE PS PEDICLE SCREWSafe Orthopaedics2013-05-03560
K122021STERISPINE LC CAGESafe Orthopaedics2012-09-20720
K121299STERISPINEPS PEDICLE SCREW, STERISPINEPS RODSafe Orthopaedics2012-07-30910
K112453STERISPINEPS PEDICLE SCREWSafe Orthopaedics2011-11-15820

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda